Class 1 Device Recall Medical Action Industries, dialysis kit

• Date Initiated by Firm: November 06, 2009
• Date Posted: March 30, 2010
• Recall Status: Terminated on June 01, 2011
• Recall Number: Z-1075-2010
• Recall Event ID: 53880
• 510(K)Number: K013621
• Product Classification: dialysis kit - Product Code FPA
• Product: Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
• Code Information: Part number: 57977, Lot numbers: 62394, 63042 and 64820.
• Recalling Firm/ Manufacturer: Medical Action Industries Inc; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Robert M. Dugan; 828-681-8820 Ext. 266
• Manufacturer Reason for Recall: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
• Quantity in Commerce: 2,520 kits
• Distribution: Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA